Controlling access to medical monitoring system

ABSTRACT

Systems and techniques for remote medical monitoring. In one implementation, a method includes monitoring a first medical condition of an individual, the monitoring being initiated remotely by a monitoring service, receiving a query relating to a second medical condition of the individual, transmitting a response to the query to the monitoring service, receiving a prompt from the monitoring service, and transmitting a response to the prompt to the monitoring service. The query is received from the monitoring service. The prompt is designed to provoke a particular action.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.11/734,644 filed Apr. 12, 2007 now U.S. Pat. No. 8,425,414, which is adivisional of U.S. application Ser. No. 11/004,311 filed Dec. 2, 2004,all of which are incorporated by reference herein in their entirety.

BACKGROUND

The following description relates to controlling access to a medicalmonitoring device and/or a service associated with the device, forexample, to help ensure that access to the monitoring device and serviceis authorized prior to commencing usage.

Advances in sensor technology, electronics, and communications have madeit possible for physiological characteristics of patients to bemonitored even when the patients are ambulatory and not in continuous,direct contact with a hospital monitoring system. For example, U.S. Pat.No. 5,959,529 describes a monitoring system in which the patient carriesa remote monitoring unit with associated physiological sensors. Theremote monitoring unit conducts a continuous monitoring of one or morephysiological characteristics of the patient according to the medicalproblem of the patient, such as the patient's heartbeat and itswaveform.

One potential issue associated with the use of such medical monitoringdevices is establishing whether the patient's health-care-benefit payerhas authorized the use of the monitoring device and service. In theabsence of a proper authorization, the patient may use the medicalmonitoring device and incur significant charges, for example, in theform of rental value of the medical monitoring device, telephonecharges, charges at the central monitoring system, and charges bymedical personnel, and the providers of those goods and services may notget paid. Bad debts—an increasing concern in the medical fieldgenerally—tend to be an even greater concern in the case of a portablemedical monitoring device and its service where the physical control ofthe device is in the hands of a third party, such as a prescribingdoctor, who does not own the medical monitoring device and is notresponsible for improper charges.

SUMMARY

The present inventors recognized a need for controlling access tomedical monitoring devices and their associated services to help ensurethat only properly authorized patients can use the service. Controllingaccess to a medical monitoring system may be accomplished by a systemand/or technique that includes one or more of the following features.

To control access to a medical monitoring system, a computer-basedmethod may involve receiving information indicating that a remotemonitoring device (e.g., a patient-portable device configured to monitorone or more physiological aspects of a patient) seeks access (e.g.,through one or more communications links including either or both of awired communication link and a wireless communication link) to amonitoring service hosted by a central unit, and determining whether theremote monitoring device is authorized to access the monitoring service.This determination is based at least in part on authorization datareceived from a third-party source. Based on a result of thedetermination, an activation signal is selectively issued to the remotemonitoring device.

The determination of whether the remote monitoring device is authorizedto access the monitoring service may be performed cooperatively betweenthe remote device and the central unit. Further, the determination ofwhether the remote monitoring device is authorized to access themonitoring service may include one or both of (i) performing a formatcheck on access data entered into the remote monitoring device and (ii)comparing the entered access data against the third-party authorizationdata.

The access control method may further include maintaining, at thecentral unit, a local database of third-party authorization data to beused in the determination of whether the remote monitoring device isauthorized to access the monitoring service. The local authorizationdatabase may be updated, for example, periodically or based on apredetermined event or a combination of both.

Selectively issuing the activation signal to the remote monitoringdevice based on a result of the determination may include issuing theactivation signal if the remote monitoring device is determined to beauthorized to access the medical monitoring service and refraining fromissuing an activation signal if the remote monitoring device isdetermined to be unauthorized to access the medical monitoring service.

In another aspect, a medical monitoring system centered at a centralnode includes one or more communications links configured to facilitatecommunications with remote monitoring devices (e.g., a patient-portabledevice configured to monitor one or more physiological aspects of apatient) and one or more third-party authorization sources. The medicalmonitoring system also includes at least one programmable processorconfigured to perform various operations. These operations may includehosting a medical monitoring service (e.g., implemented at least in partby one or more software processes), receiving information indicatingthat a remote monitoring device seeks access to the medical monitoringservice hosted by a central unit, determining, based at least in part onauthorization data received from a third-party authorization source,whether the remote monitoring device is authorized to access themonitoring service, and based on a result of the determination,selectively issuing an activation signal to the remote monitoringdevice.

The programmable processor may further be configured to maintain at thecentral node a local database of third-party authorization data to beused in the determination of whether the remote monitoring device isauthorized to access the monitoring service. The local authorizationdatabase may be updated based on data received from the one or morethird-party authorization sources. Updating may occur periodically orbased on a predetermined event or a combination of both.

The programmable processor may further be configured to determinewhether the remote monitoring device is authorized to access themonitoring service by one or both of (i) performing a format check onaccess data entered into the remote monitoring device and (ii) comparingthe entered access data against the third-party authorization data.

The programmable processor may be configured to issue the activationsignal to the remote monitoring device if the remote monitoring deviceis determined to be authorized to access the medical monitoring serviceand to refrain from issuing an activation signal if the remotemonitoring device is determined to be unauthorized to access the medicalmonitoring service.

In another aspect, a portable medical monitoring device includes atransceiver for communicating with a central node, a user interface forcommunicating with a user of the device, and a programmable processorconfigured to perform various operations. These operations may includereceiving user input specifying user-specific information, transmittingthe received user input to the central node for third-partyauthorization based at least in part on the user-specific information,and selectively providing the user with access to a monitoring servicehosted at the central node based on a result of the third-partyauthorization.

The programmable processor further may be configured to perform a formatcheck on the received user input to determine whether the user inputmeets one or more predetermined criteria. If the user input isdetermined not to meet one or more of the predetermined criteria, theprogrammable processor may refrain from transmitting the received userinput to the central station and/or may deny access to the monitoringservice. In addition, the programmable processor may be configured toprovide access to the monitoring service if the device receives anactivation signal from the central node and to deny access to themonitoring service if the device fails to receive an activation signalfrom the central node.

Among other potential advantages, the systems and techniques describedhere may facilitate controlling access to medical monitoring devices andassociated services. The approach may help to ensure that the term ofservice is initiated and continued only for persons who are properlyauthorized to have the service. For example, the present approach mayactivate the medical monitoring device and its corresponding serviceonly for a person who provides proper identification data and isfinancially and otherwise properly authorized for the service. As aresult, the chances of a wrong person being monitored may tend to bereduced. The activation process, which may involve the input of properidentification data, may be quick and largely transparent to the personseeking the service.

The systems and techniques described here may help to ensure thatmedical monitoring device services are provided only to properlyidentified and authorized persons. They may also help to ensure that allpersons and agencies responsible for the medical monitoring device andthe services are coordinated in their approval of rendering service tothe particular patient and in effect have approved the provision ofservice and the type of service to be provided. Potential legal andfinancial liability may thereby be reduced.

In another aspect, a method includes monitoring a first medicalcondition of an individual, receiving, from the monitoring service, aquery relating to a second medical condition of the individual,transmitting a response to the query to the monitoring service, andreceiving a prompt from the monitoring service, the prompt designed toprovoke a predetermined action. The monitoring can be initiated remotelyby a monitoring service.

This and other aspects can include one or more of the followingfeatures. A response to the prompt can be transmitted to the monitoringservice. The received prompt can be designed to provoke the monitoredindividual to undertake the predetermined action. The query can be,e.g., a blood glucose query inquiring as to a blood glucoseconcentration of the individual, a blood pressure query inquiring as toa blood pressure of the individual, or a weight query inquiring as to aweight of the individual.

The prompt received from the monitoring service can be, for example, amedication prompt designed to provoke the monitored individual tomedicate, a sample prompt designed to provoke the collection of asample, an electrode check prompt designed to move the monitoredindividual to check an electrode, or a communications check promptdesigned to move the monitored individual to ensure that communicationswith the monitoring service are maintained. The prompt can also be abattery check prompt designed to move the monitored individual to checka charge on the battery, a physical activity prompt designed to move themonitored individual to curtail or halt physical activity, or a promptdesigned to move the monitored individual to lie down or sit down.

The can also include receiving input from the monitored individual andusing the input in responding to the query. Monitoring the first medicalcondition can include monitoring cardiac function of the individual.

In another aspect, a machine-readable medium can store instructionsoperable to cause one or more devices to perform operations. Theoperations can include monitoring a medical condition of an individual,transmitting a result of the monitoring to a monitoring service,receiving an activity prompt from the monitoring service, prompting theactivity related in the activity prompt, and transmitting a response tothe prompt to the monitoring service. The activity prompt can relate anactivity that is to be prompted.

This and other aspects can include one or more of the followingfeatures. The activity can be prompted by relaying the prompt to themonitored individual and receiving a response to the relayed prompt fromthe monitored individual. The prompted activity can be the collection ofa sample. For example, the collection of the result of the monitoringcan be provoked or the monitored individual can be provoke to medicatewith a specific medication. For example, the monitored individual can beprovoked to medicate using a pharmaceutical composition having aspecific color.

The operations can also include receiving a query from the monitoringservice. The query can relate to a second medical condition of theindividual. The operations can also include receiving adapted parametersfor the monitoring of the medical condition of the individual, andadapting the monitoring of the medical condition in accordance with thereceived parameters. The response can be transmitted without input fromthe monitored individual.

In another aspect, a method includes receiving a monitoring result froma remote monitoring device, receiving, from the remote monitoringdevice, a response to one or more of a prompt to provoke a specificaction and a query regarding a second medical condition of theindividual; and adapting the monitoring of the first medical conditionof the individual by the remote monitoring device based on the receivedresponse. The remote monitoring device remotely monitors a first medicalcondition of an individual.

This and other aspects can include one or more of the followingfeatures. Receiving the response can include receiving a response to oneor more of an individual-specific prompt and an individual-specificquery tailored to the monitored individual. The monitoring result andthe response can be stored. To adapt the monitoring, adapted monitoringparameters can be transmitted to the remote monitoring device. Forexample, adapted parameters for the identification of cardiac states canbe transmitted to the remote monitoring device.

In another aspect, a method of conducting a clinical trial includesremotely prompting an individual to medicate in accordance with aregimen of the clinical trial and remotely monitoring a cardiac functionof the individual during the medication over a remoteelectrocardiographic monitoring device.

This and other aspects can include one or more of the followingfeatures. A response to the prompt indicating that the individual hasindeed medicated in accordance with the clinical trial can be received.The individual can be prompted to take a specific pharmaceuticalcomposition, and the efficacy or safety of the prompted medication canbe determined. The individual can be remotely prompted over the remoteelectrocardiographic monitoring device.

In another aspect, a method performed at a central monitoring systemincludes receiving, from a remote sensing device, information related toa medical condition of a monitored individual associated with the remotesensing device and, based at least in part on the received information,transmitting, to the remote sensing device, information designed toinstruct the monitored individual.

This and other aspects can include one or more of the followingfeatures. The information designed to instruct the monitored individualcan include instructions to undertake a predetermined action. Forexample, the instructions to undertake a predetermined action caninclude transmitting instructions to take medicine, transmittinginstructions to contact a doctor, transmitting instructions to sit down,transmitting instructions to reduce altitude, transmitting instructionsto reduce an activity level, transmitting instructions to measure one ofblood pressure or glucose, transmitting instructions to enter a responseor other information for transmission back to the central monitoringsystem.

The information designed to instruct the monitored individual can alsoinclude information associated with the medical condition, informationdesigned to confirm receipt of the received information, or informationassociated with treatment of the medical condition. For example, animage of a medication to treat the medical condition can be transmitted.

The information designed to instruct the monitored individual can betransmitted periodically. The period can change between transmissionsbased on the received information. The information can also betransmitted in response to an event identified in the receivedinformation.

In another aspect, a method performed by a medical condition sensingdevice associated with a monitored individual can include measuring aphysiological condition of the monitored individual, transmitting themeasured physiological condition to a central monitoring system, andreceiving information designed to instruct the monitored individual fromthe central monitoring system. The received information can be based atleast in part on the measured physiological condition.

This and other aspects can include one or more of the followingfeatures. The information designed to instruct the monitored individualcan include instructions to undertake a predetermined action. Theinstructions to undertake a predetermined action can include, e.g.,instructions to take medicine, instructions to contact a doctor,instructions to sit down, instructions to reduce altitude, instructionsto reduce an activity level, instructions to measure one of bloodpressure or glucose, instructions to enter a response or otherinformation for transmission back to the central monitoring system.

The information designed to instruct the monitored individual caninclude information associated with the medical condition, informationdesigned to confirm receipt of the received information, or informationassociated with treatment of the medical condition. For example, animage of a medication to treat the medical condition can be received.

The information designed to instruct the monitored individual can bereceived periodically. The period can change between transmissions basedat least in part on the transmitted physiological condition. Theinformation designed to instruct the monitored individual can bereceived in response to an event identified in the transmittedphysiological condition.

The details of one or more implementations are set forth in theaccompanying drawings and the description below. Other features will beapparent from the description and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a flow diagram of a method of controlling access to a medicalmonitoring device and/or an associated service.

FIGS. 2A and 2B are schematic illustrations of medical monitoringsystems for implementing the method of FIG. 1.

FIG. 3 is a flowchart of a process that can be performed by a medicalmonitoring device system during its term of service.

FIG. 4 shows a table of example medical queries that can be handledduring the term of service of a medical monitoring device.

FIG. 5 is a flowchart of a process that can be performed by a medicalmonitoring device system during its term of service.

FIG. 6 shows a table of example activity prompts that can be handledduring, the term of service of a medical monitoring device.

FIG. 7 shows a data store for storing information during the term ofservice of a medical monitoring device.

FIG. 8 is a flowchart of a process that can be performed by a centralunit in response to receipt of information from a medical monitoringdevice system.

FIG. 9 is a schematic illustration of another implementation of amedical monitoring system.

FIG. 10 is a flowchart of a process that can be performed by aelectrocardiograph monitoring system during a clinical trial.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

FIG. 1 depicts a flow diagram of a method of controlling access to amedical monitoring device and/or service. A medical monitoring deviceand its associated system are provided (20). The medical monitoringdevice and medical monitoring system may be of any operable type, suchas that disclosed in U.S. Pat. No. 5,959,529 (hereafter, “the '529patent”), whose disclosure is incorporated in its entirety, and/ormodified as discussed herein.

FIGS. 2A and 2B depict details, in block diagram form, of medicalmonitoring systems 50 that include a medical monitoring device system52. Medical monitoring device systems 52 include one or more medicalmonitoring devices that monitor a biological parameter. A biologicalparameter is a quantity that characterizes an aspect of a biologicalsystem. In the medical context, biological parameters generally includeinformation relating to the physiological state of an organism. Examplesof medical monitoring devices include devices that measure electricalpotentials (e.g., electrocardiography (ECG's), electromyography, andelectroencephalography devices), devices that measure blood and otherbody fluid analyte constituents (e.g., pulse oximetry devices anddevices that measure blood glucose concentration, blood pH, and/or otherion concentrations), and devices that measure mechanical characteristics(e.g., blood pressure transducers, heart sound transducers, heightand/or weight measurement devices).

In FIG. 2B, medical monitoring device system 52 includes both a medicalmonitoring device 54 and a base station 56. The medical monitoringdevice 54 may be a portable or remote monitoring unit of the typegenerally described in the '529 patent. The base station 56 hascommunication access to a central unit 58 through a communication linksuch as a wireless cellular telephone transceiver link 60 and/or atelephone land-line 62. Alternatively, or in addition, communicationlinks can be established by other available means, among others, such aswired or wireless networks that implement communications protocols andstandards such IP (Internet protocol), WiFi (IEEE 802.11x), WiMax (IEEE802.16x), and GPRS (General Packet Radio Service). The central unit 58,typically maintained at a central node or location, may in practice becomposed of multiple computer systems distributed across, or evenoutside of, the central node.

In other implementations, medical monitoring device 54 can have directcommunication access to central unit 58 through a communication link.For example, medical monitoring device 54 can include a cellulartransceiver to establish a direct wireless cellular telephonetransceiver link to central unit 58.

In the implementation shown in FIG. 2B, the base station 56 has a basestation cradle 64 that is configured to receive the medical monitoringdevice 54. The medical monitoring device 54 includes an input/outputdevice 65 that typically has a microprocessor, communicationscontroller, and communications hardware and/or software to establish thelinks 60 and/or 62. The input/output device 65 has a keypad 66 forinputting information and a display 68 to view the input information andother information to be displayed, as well as information transmitted tothe input/output device 65. Alternatively, input/output device 65 canuse a touch-sensitive display without dedicated keys to interact with auser.

In the implementations shown in FIGS. 2A and 2B, the central unit 58 hascommunications access to a variety of databases 71 and to third-partysources 72, typically by telephone land-line, network or otherconnection 70. The databases 71 may include prior patient records,general records, and the like. The third-party sources 72 may include,for example, financial sources 74, medical sources 76, and other sources78. A financial source might be, for example, an insurance company, thesocial-security administration, or a credit-granting company. A medicalsource might be, for example, a specialist physician whose authorizationis required before commencing the monitoring of the patient. Otherthird-party sources might be, for example, the company that maintainsthe medical monitoring device and which is consulted to be certain thatthe specific medical monitoring device to be activated is approved forservice.

In the implementation shown in FIG. 2B, the base station 56, when notprescribed or otherwise assigned and distributed to a patient to bemonitored, ordinarily is in the custody the office of the agency that isproviding the medical monitoring device 54 to a patient for the purposeof monitoring physiological parameters of the patient. Such an agencycould be, for example, the patient's physician or a hospital. When theagency undertakes to provide the medical monitoring device 54 to thepatient, for example, to take home, the medical monitoring device 54 isdocked with the base station 56, and the procedures described inrelation to subsequent portions of FIG. 1 are followed.

Returning to FIG. 1, a set of identification data elements (22) areinput into the medical monitoring device system 52. For example, a setof identification data elements can be input through the keypad 66 ofthe input/output device 65 of the medical monitoring device 54 of FIG.2B. The identification data elements may include, for example, one ormore of a patient name, a patient address, a patient social securitynumber, a patient sex, and an identification of the third-partyfinancial source. In one implementation, a set-up sequence may involvethe input of a patient number or other patient identifier. The inputpatient identifier can be used to retrieve other information about thepatient, including name, address, social security number, sex, and theidentity of a third-party financial source. The identifier of themedical monitoring device 54, such as its serial number, may be manuallyinput in step 22, but more typically the identifier is automaticallymade available by the medical monitoring device 54 to the base station56.

The input/output device 65 may perform a preliminary evaluation of theset of identification data elements, for example, such as to determineby using a software utility program whether the identification dataelements meet a set of one or more format requirements. Such basicformat requirements may be specified for each of the identification dataelements. For example, a format requirement may specify that a patientname is to include only alphanumeric characters. If as typed into thekeyboard the patient name includes other characters (e. g., a percentsign %), software running in the input/output device 65 can recognizethe error and provide an input diagnostic message through the display 68to prompt the input of correct information. In another example, a formatrequirement may specify that a user's social security number mustcontain 10 numerical digits and may not contain letters or othercharacters.

After what appears from the preliminary format evaluation to be a set ofcorrect identification data elements is input to the input/output device65, the medical monitoring device system 52 establishes (24) acommunication link to the central unit 58. The communication link ispreferably through the land-line 62, but may be though the cellulartelephone transmission link 60 or another wireless or wired link if theland-line is not available.

The medical monitoring device system 52 and the central unit 58cooperatively determine whether the medical monitoring device may beactivated for rendering medical monitoring device service (26). Thefinal decision is typically made by the central unit 58, although themedical monitoring device system 52 may aid in data processing or may becalled upon for additional input, for example, such as when the patientname is found not to match with the social security number in otherrecords.

The activation determination process 26 may include varioussub-processes including evaluating the set of identification dataelements as to whether they meet a set of basic structural requirements(28) and obtaining third-party authorization (30) from one or more ofthe third-party sources 72. The sub-processes of evaluating 28 andobtaining 30 are preferably performed automatically. “Automatically” asused herein indicates that the steps are performed without human actionor intervention, except where a discrepancy occurs. The present systemis organized to perform the evaluating and obtaining steps entirely bycomputer procedures, to minimize costs and take advantage of datacollections at a variety of locations. Alternatively, the presentapproach may be performed in whole or in part using manual (i.e.,human-performed) sub-processes 28 and 30. In addition, the sub-process30 of obtaining third-party authorization can be performed either beforeor during the activation determination process 26. For example, thesub-process 30 may involve updating a locally stored (e.g., at a centralunit hosting the medical monitoring service) copy of a third party'sdatabase of authorization information, and then performing thesub-process 30 by accessing the local copy of the database instead ofaccessing the third party's system, which typically would be maintainedat a remote location. Updating of the local third-party authorizationdatabase may occur based on one or both of the following criteria: (i)periodically (e.g., once a day) or (ii) based on an occurrence of apredetermined event (e.g., the third-party system determines that acertain amount of new authorization data is available and has not yetbeen copied to the central unit's local database and/or the central unitdetermines that its local database does not contain needed information).

The set of basic structural requirements to be imposed may include theformat requirements evaluated by the input/output device 65, or mayinclude different or additional structural requirements. For example,the central unit 58 may check the database 71 to attempt to match theinput patient name with a social security number that is already in thedatabase 71 from prior medical contacts. If the patient name and thesocial security number that were input in sub-process 22 do not match,then further inquiry may be made back to the medical monitoring devicesystem 52. The failure to match the name and the social security numbermay arise from a simple inputting error, which can be corrected withrevised input, or it may arise from a fraudulent attempt to obtainmedical monitoring services that is detected by the procedures ofsub-process 28.

As noted above, obtaining third-party authorization in sub-process 30may include contacting appropriate third-party sources 72, e.g., eitheron a dynamic, as-needed basis, and/or ahead of time by periodicallyreplicating a third party's remote database to create a local copy. Thefinancial source 74 may be contacted to determine whether it authorizesthe charges associated with the patient monitoring services. Thisauthorization is particularly important for the business interests ofthe provider of the services, for example, to avoid unpaid billings.Unpaid billings for medical services represents a major loss for manymedical service companies. The medical source 76 may be contacted todetermine whether it authorizes the patient monitoring. For example, ifthe prospective patient is being treated by more than one physician, itmay be important to obtain authorization from each physician who istreating the patient before medical monitoring services are commenced.In this case, “authorization” signals formal recognition by theauthorizing party that monitoring information will be available. Othersources 78 may also be contacted to determine whether they authorize thepatient monitoring. For example, it may be desirable to ensure that thecompany responsible for maintaining a specific medical monitoring deviceauthorizes its use. If a prior user had reported a problem and thespecific medical monitoring device had been taken out of service forrepair, but was mistakenly to be re-activated without being repaired,the company responsible for the maintenance could prevent its activationat this stage.

Thus, the procedures in sub-process 26 act as a “sign off” by a numberof checks and third-parties to minimize the possibility that a medicalmonitoring device will be wrongly issued to a patient and activated. Ifthe sign-offs are not completed, the medical monitoring device is notactivated until the reason for the non-completion may be investigated.It is expected that in the great majority of cases, the activationdetermination process 26 will be completed without incident and sorapidly that the checking will be transparent to the patient and theissuer of the medical monitoring device.

Based on results of the activation determination process, the activationdecision is made (32). The final decision is typically made at thecentral unit 58, although all or part of the final decision could bemade at the base station and/or distributed or made by a system atanother location. Typically, the decision is made at the central unit 58because it has the access to the required information during theactivation determination process 26, and because the central unit 58tends to be more immune to tampering than the input/output device 65.

In the event that the identification data elements meet the set of basicstructural requirements and third-party authorization is obtained, thecentral unit 58 issues an activation signal (34) to the medicalmonitoring device system 52 over the communication link 60 or 62. Themedical monitoring device is activated and enters service (36).

The “activation signal” may be of any operable type. It may be asoftware “on” switch that enables the processing of data within amicroprocessor in the medical monitoring device or a hardware “on”switch that turns on particular hardware functions such as thecommunications links built into the medical monitoring device. Theactivation signal may be complex, and may include identification of thepatient and the specific medical monitoring device that is associatedwith that patient. This activation signal may then be transmitted witheach subsequent communication between the medical monitoring device andthe central unit 58 for identification purposes. In the event that theproper activation signal is not transmitted with each communication, itmay be ignored. The activation may be revoked (38) at a later time ifthe authorization is withdrawn or for other reasons. Upon revocation 38,the signals transmitted by the medical monitoring device are not actedupon, and the patient and/or the issuing authority are notified andrequested to return the medical monitoring device. As an alternative torevocation 38, the activation signal of step 34 may include a maximumtime limit for which activation is authorized, so that a furtherauthorization is required to extend the period of authorized use.

FIG. 3 shows a process 300 that can be performed during the term ofservice of a medical monitoring device. Aspects of process 300 performedby a central unit such as central unit 58 are denoted by arrow 305,whereas aspects of process 300 performed by a medical monitoring devicesuch as device 54 are denoted by arrow 310. In process 300, a centralunit sends a medical query to a medical monitoring device system at 315.A medical query is an inquiry regarding the medical condition of anindividual who is monitored by a medical monitoring device.

FIG. 4 shows a table 400 that identifies example medical queries 405,410, 415, 420. Medical query 405 is an inquiry regarding the medicationof an individual. For example, medical query 405 can inquire whether ornot the individual has recently medicated with a particular medicationor medical query 405 can inquire as to the dosage at which theindividual has medicated. Medical query 410 is an inquiry regarding theindividual's blood glucose concentration. Medical query 415 is aninquiry regarding the individual's blood pressure. Medical query 420 isan inquiry regarding the individual's weight.

Medical queries can be patient-specific in that they are relevant to themedical state of an individual or to classes of individuals. Medicalqueries can be tailored to the individual's medical condition, location,or activities. Medical queries can address a number of different diseasestates, including those outside the purview of the primary function ofthe medical monitoring device system. For example, when the medicalmonitoring device system is an electrocardiograph, medical queries caninclude queries directed to an individual's diabetic condition.

In addition, medical queries can be periodic queries made at certainfixed intervals during the monitoring of an individual. For example,periodic queries as to an individual's blood pressure can be made everyfour hours or so, whereas periodic queries as to an individual's weightcan be made every three months or so. Medical queries can also be “onetime” queries in that they are made during the onset of monitoring. Suchqueries can inquire as to the individual's age, gender, and medicalhistory. Medical queries can also be “dynamic” queries in that thefrequency at which the queries are made is adjusted based on theresponses to previous queries or the responses to previous activityprompts, as discussed below. For example, when a response to a bloodglucose query 410 indicates that the individual's blood glucose level isfalling, the frequency of subsequent blood glucose queries 410 can beincreased until the individual's blood glucose level ceases to fall orbegins to increase.

Returning to FIG. 3, the transmitted medical query is received at amedical monitoring device at 320. The medical query can be received overa wireless communication link and/or a wired communication link. Themedical monitoring device can then prepare a response to the receivedmedical query at 325. The preparation of the response can be performedautomatically, i.e., without input from the individual who is monitored.For example, the response can be prepared using monitoring results readfrom a sensor. Alternatively, the response can be prepared based oninput from the individual who is monitored. For example, the medicalmonitoring device system can present a text version of the medical queryto the monitored individual. The medical monitoring device system canthen receive information used to frame a response over one or more inputdevices.

Once the response is prepared, the medical monitoring device cantransmit the prepared response to a central unit at 330. The responsecan be transmitted over a wireless communication link and/or a wiredcommunication link. The central unit can receive the response to themedical query at 335. The received response can be stored in a medicallibrary that includes other information relating to the medicalcondition of the monitored individual at 340. One implementation of suchstorage is discussed further below.

FIG. 5 shows a process 500 that can be performed during the term ofservice of a medical monitoring device system. Aspects of process 500performed by a central unit such as central unit 58 are denoted by arrow505, whereas aspects of process 500 performed by a medical monitoringdevice such as device 54 are denoted by arrow 510.

In process 500, a central unit sends an activity prompt to a medicalmonitoring device at 515. An activity prompt is a trigger designed toprovoke a particular action. FIG. 6 shows a table 600 that identifiesexample activity prompts 605, 610, 615, 620, 625, 630. Activity prompt605 is a trigger designed to provoke a monitored individual to medicatein a certain way. For example, activity prompt 605 can identify amedication and a dosage for the medication that is to be taken by themonitored individual. The medication can be identified, e.g., by name,by ID #, by shape, or by color. Medication can also be identified usinga visual display device that presents an image of the medication (e.g.,a purple, ovoid capsule) to identify the medication. Activity prompt 610is a trigger designed to provoke the collection of a sample. Forexample, activity prompt 610 can provoke a monitored individual to takea urine sample or a blood sample. Activity prompt 610 can also prompt anindividual to facilitate monitoring using a medical monitoring devicesystem. For example, when the medical monitoring device system is aelectrocardiograph, activity prompt 610 can prompt the monitoredindividual to ensure that electrodes are connected, to minimize theamount or type of movement, or to recline for collection of anelectrocardiograph signal sample.

Activity prompt 615 is a trigger designed to provoke a monitoredindividual to check that any electrodes of the medical monitoring deviceare deployed properly. For example, activity prompt 615 can provoke amonitored individual to check that contact between the monitoringelectrodes and the proper portion of and/or location on the body ismaintained. Activity prompt 620 is a trigger designed to provoke amonitored individual to check that a battery or other power source forthe medical monitoring device is sufficiently charged to properly supplythe medical monitoring device with power. Activity prompt 625 is atrigger designed to provoke a monitored individual to check and decreasehis or her altitude. In particular, individuals with certain medicalconditions may be respond unfavorably to altitudes and activity prompt625 may act to remind them to consider altitude during activities.Activity prompt 630 is a trigger designed to provoke a monitoredindividual to consider the likelihood of losing one or morecommunications links with the central unit. For example, activity prompt630 can be triggered when a signal over a wireless communication link isfading.

Activity prompts can also be patient-specific in that they are relevantto the monitored individual or to classes of individuals. Activityprompts can be tailored to the individual's medical condition, location,or activities. Activity prompts can address a number of differentdisease states, including those outside the purview of the primaryfunction of the medical monitoring device system. For example, when themedical monitoring device system is an electrocardiograph, activityprompts can include queries directed to an individual's participation ina clinical trial, as discussed below.

Activity prompts can also be periodic in that they are made a certainfixed intervals during the monitoring of an individual. For example,periodic prompts to medicate can be made in accordance with anindividual's medication regimen. Activity prompts can also be “one time”prompts in that they are made during the onset of monitoring. Activityprompts can also be “dynamic” prompts in that the frequency at which theprompt are made is adjusted based on the responses to previous promptsor the responses to previous queries. For example, when responses toaltitude check prompts 625 consistently indicate that an individual isat or near sea level, the frequency of altitude check prompts 410 can bedecreased until an anomalous response is obtained.

Additional examples of activity prompts include triggers designed toprovoke a monitored individual to, e.g., lie down, sit down, curtail orhalt physical activity, commence or increase physical activity, applypressure to a wound, contact a doctor, call an ambulance, decreasealtitude, measure blood glucose level, measure blood pressure, take adiuretic, or hydrate.

Returning to FIG. 5, the transmitted activity prompt is received at amedical monitoring device at 520. The activity prompt can be receivedover a wireless communication link and/or a wired communication link.The medical monitoring device can prompt the desired activity at 525.Such prompting can be directed to the monitored individual or to otherelements in the medical monitoring device. In one implementation, amessage is presented to the monitored individual over an output devicesuch as an LCD screen. In another implementation, data collectionelements in the medical monitoring device are directed to collect acertain sample.

The medical monitoring device can also prepare and transmit a responseto the received activity prompt at 530. The preparation of the responsecan be done automatically, i.e., based on sensor readings and withoutinput from the individual who is monitored. For example, when themedical monitoring device system is an electrocardiograph, the preparedresponse can include electrocardiogram data. Alternatively, thepreparation of the response can be based on input from the individualwho is monitored. For example, the medical monitoring device can presenta text version of the activity prompt to the monitored individual andthen receive a response over one or more input devices.

Once the response is prepared, the medical monitoring device system cantransmit the prepared response to a central unit at 530. The responsecan be transmitted over a wireless communication link and/or a wiredcommunication link. The central unit can receive the response to theactivity prompt at 535. The received response can be stored in anactivity library that includes other information relating to otheractivities of the monitored individual at 540.

FIG. 7 shows a data store 700 suitable for storing one or more activitylibraries 705 and one or more medical libraries 710. Activity library705 includes a collection of activity records 715 that describeindividual activities that have been prompted by the central unit. Forexample, each activity record 715 can include a time prompt sent field720, a prompt origin field 725, a nature of prompt field 730, a timeresponse received field 735, and a response field 740. Time prompt sentfield 720 includes information identifying the time when the prompt wastransmitted from the central unit to the medical monitoring devicesystem. Prompt origin field 725 includes information identifying thecause of the prompt. For example, an altitude check prompt may be sentwhen a monitored condition at the medical monitoring device systemindicates that altitude may be a factor in the medical condition of themonitored individual. The monitored condition can be, e.g., a geographiclocation identified using a global positioning satellite (GPS) readingtaken by the device.

Nature of prompt field 730 includes information identifying the subjectof the transmitted prompt. For example, nature of prompt field 730 canidentify the activity that was designed to be triggered. Time responsereceived field 735 can include information identifying the time when aresponse to the prompt was received. Response field 740 can includeinformation identifying the response received. For example, responsefield 740 can identify that the monitored individual has taken theprompted medication or that the monitored individual has collected abiological sample.

Medical library 710 includes a collection of medical records 745 thatdescribe responses to queries by the central unit. For example, eachmedical record 745 can include a time query sent field 750, a queryorigin field 755, a nature of query field 760, a time response receivedfield 765, and a response field 770. Time query sent field 750 includesinformation identifying the time when the query was transmitted from thecentral unit to the medical monitoring device system. Query origin field755 includes information identifying the cause of the query. Forexample, a query regarding the monitored individual's blood glucoselevel can be sent in response to the passage of a fixed period of timeand a medication query may be sent in response to an anomalousmeasurement by the medical monitoring device system.

Nature of query field 760 includes information identifying the subjectof the transmitted query. For example, nature of query field 760 canidentify that the query is one or more of the queries in table 400 (FIG.4). Time response received field 765 can include information identifyingthe time when any response to the query was received. Response field 770can include information identifying the response received. For example,response field 770 can identify that the monitored individual is notmedicated or that the monitored individual has a certain blood pressure.

Libraries 705, 710 can be implemented in virtually any sort of datarepository including databases, data tables, linked lists, or otherassociations of records 715, 720. Records 715, 720 can be data objects,data records, or other associations of information. Associations betweendata in libraries 705, 710 and records 715, 720 can be formed using,e.g., directories, files, filenames, or pointers. Libraries 705, 710 andrecords 715, 720 can be stored in a single data storage device orlibraries 705, 710 and records 715, 720 can distributed among two ormore data storage devices.

FIG. 8 shows a process 800 that can be performed by a central unit inresponse to receipt of a response to a medical query, receipt of aresponse to an activity prompt, or receipt of other information from amedical monitoring device system. For example, process 800 can beperformed by central unit 58 (FIG. 2).

The system performing process 800 receives the response or otherinformation at 805. The response can be received over a wired or awireless data communications link.

In response to receipt of the response, the system can distribute theresponse to one or more third parties to whom the response is relevantat 810. For example, if the response indicates that a sample has beencollected, the information regarding the collection can be distributedto a physician, a manager of a clinical trial, or other concerned party.In the case of sensor readings or other data samples, the distributedinformation can include the collected sample itself.

The system performing process 800 can also adapt the parameters of themonitoring performed by the medical monitoring device system at 815. Theparameters can be adapted, e.g., to change thresholds at which diseasestates are identified, to change the algorithms used in monitoring, orto change the nature of the monitoring itself. The adaptation of theparameters can be based on the response or other information receivedfrom the medical monitoring device system or the adaptation can be basedon input from the third party to whom the response or other informationhas been distributed.

After adapting the parameters of the monitoring, the system can transmitthe adapted parameters to the medical monitoring device system at 820.The transmission can result in the medical monitoring device systemadapting the monitoring to accord with the transmitted parameters.

FIG. 9 shows another implementation of a medical monitoring system 50for monitoring an individual 105. Medical monitoring system 50 includesmedical monitoring device system 52 in communication with central unit58 over one or more communication links 80.

Medical monitoring device system 52 can be adapted forelectrocardiographic monitoring of an individual 105. Medical monitoringdevice system 52 can include a sensor module 905 and a monitor module910. Sensor module 905 can include three ECG leads with electrodes, aswell as a two channel ECG signal recorder and a wireless and/or wireddata output. Sensor module 905 can also include a clip for attachingsensor module to a belt, a neckpiece, or other item worn by individual105. Monitor module 910 includes a data input that is adapted to receivedata output from sensor module 905 as well as one or more wirelessand/or wired data outputs for data communication over communication link80. Monitor module 910 also includes a data processing device thatperforms data processing activities in accordance with the logic of aset of machine-readable instructions. The instructions can be realizedin digital electronic circuitry, integrated circuitry, speciallydesigned ASICs (application specific integrated circuits), computerhardware, firmware, software, and/or combinations thereof. Theinstructions can describe how to identify and/or handleelectrocardiogram data in accordance with one or more of the techniquesdescribed herein. Monitor module 910 can also include an input deviceand an output device for interaction with a user. The output device canpresent a prompt or a query to the monitored individual. The inputdevice can receive information used in framing a response to a presentedprompt or query.

Communication link 80 can include one or both of a wired data link 915and a wireless data link 920 coupled to a data network 925 to placemedical monitoring device system 52 in data communication with centralunit 58. Wired data link 915 includes a public network portion 930 and aprivate or virtual private network portion 935 bridged by a server 940.Public network portion 930 provides for data communication betweenmedical monitoring device system 52 and server 940 over a wired datalink such as a telephone network. Private network portion 935 providesfor private or virtually private data communication from server 940 toreceiver 120. Server 940 can interface for data communication with bothportions 930, 935. For example, server 940 can communicate directly withcentral unit 58 using the peer-to-peer protocol (PPP).

Wireless data link 945 can include one or more wireless receivers andtransmitters 950 such as a WiFi receiver, a cellular phone relaystation, and/or other cellular telephone infrastructure to place medicalmonitoring device system 52 in data communication with data network 925.In turn, data network 925 communicates with central unit 58.

Central unit 58 includes a receiver server 955, a data storage device960, a call router 965, a communications server 970, and one or moreapplication servers 975 that are all in data communication with oneanother over one or more data links 980. Receiver server 955 is a dataprocessing device that receives and transmits communications overcommunications link 80 and relays incoming communications to datastorage device 960 and call router 965 in accordance with the logic of aset of machine-readable instructions. Data storage device 960 is adevice adaptable for the storage of information. For example, datastorage device 960 can store one or more activity libraries 705 and/ormedical libraries 710 (FIG. 7). Data storage device 960 can be avolatile and/or non-volatile memory that records informationelectrically, mechanically, magnetically, and/or optically. Call router965 is a data processing device that, in accordance with the logic of aset of machine-readable instructions, identifies the content of anincoming communication and directs the communication to one or moreappropriate application servers 975 based on that content.Communications server 970 is a data processing device that relayscommunications between call router 965 and one or more applicationservers 975 over an external network. Application servers 975 are dataprocessing devices that interact with a user or operate in isolation toprovide one or more monitoring services in accordance with the logic ofa set of machine-readable instructions. Data links 980 can be part of alocal area and/or private network or part of a wide area and/or publicnetwork.

In operation, sensor module 905 can sense, amplify, and recordelectrical signals relating to the activity of the heart. Sensor module905 can also relay all or a portion of those signals to monitor module910 where they can be managed. For example, monitor module 910 canmanage the signals in accordance with one or more of processes 300 and500 (FIGS. 3 and 5). As part of the management, monitor module 910 cantransmit the signals to central unit 58. The signals can be transmittedalone or in association with other information. For example, the signalscan be transmitted in association with other information that isresponsive to queries or prompts.

The transmitted signals pass along communications link 80 over one ormore of wired data link 915 and wireless data link 920 to central unit58. At central unit 58, the signals are received by server 955 whichcauses at least a portion of the incoming signals to be stored on datastorage device 960 and relayed to call router 965. The incoming signalsstored on data storage device 960 can be stored any of a number of datastructures.

The incoming signals relayed to call router 965 can be distributed toone or more appropriate application servers 975. The distribution can bebased on one or more different factors, including the load on certainapplication servers 975, the resources available at certain applicationservers 975 (e.g., the amount and/or type of memory available), or thecontent of the incoming signals. For example, when the signal relates toa certain category of cardiac event, the signal can be distributed to acertain application server 975 that is accessible to a cardiologisthaving expertise with that certain category of event. As anotherexample, when the signal originates with an individual who is under thecare of a particular physician, the signal can be distributed to acertain application server 975 that is accessible to that physician. Asyet another example, when the signal relates to a certain category ofcardiac event, the signal can be directed to a certain applicationserver 975 that accesses an expert system or other set of instructionsfor diagnosing and/or treating that category of event. When appropriate,a signal can be routed to communications server 970 which in turn relaysthe signal to the appropriate application server 975 over an externalnetwork.

Communications can also be transmitted from central unit 58 back toindividual 105 or to other individuals, as discussed above. As yetanother example, when a physician or expert system identifies that careis needed, a message requesting that the individual seek care can bereturned to individual 105 over communication link 80. In urgent caresituations, third parties such as medical personnel can be directed toindividual 105 by medical monitoring device system 52.

FIG. 10 shows a process 1000 that can be performed using anelectrocardiographic monitoring device during a clinical trial. Aclinical trial is an experiment involving a set of human subjects havinga clinical event as an outcome measure. Clinical trials are generallydesigned to yield information about the efficacy or safety of a drug,vaccine, diagnostic test, surgical procedure, or other medicalintervention. For the sake of convenience, such interventions arereferred to herein as “medication.”

Aspects of process 1000 performed by a central unit such as central unit58 are denoted by arrow 1005, whereas aspects of process 1000 performedby an electrocardiographic monitoring device are denoted by arrow 1010.

In process 1000, a central unit sends a medication prompt to anelectrocardiograph system at 1015. The medication prompt is designed totrigger the monitored individual to medicate in accordance with theguidelines of the clinical trial. For example, the medication prompt canprompt the monitored individual to take a specified dosage of aspecified pharmaceutical composition at a specified time. The medicationprompt can be tailored to the monitored individual and based on factorssuch as the individual's weight, activity level, age, and medicalhistory. The prompted medication need not be thought to have a directconsequence on cardiac function, but rather the prompted medication canbe suspected of having a minimal effect or of having no effect oncardiac activity.

The transmitted medication prompt is received at the electrocardiogramsystem at 1020. The electrocardiogram system can then prompt theappropriate medication at 1025. For example, the electrocardiogramsystem can direct the monitored individual to dose with a specificmedication in accordance with the clinical trial. The electrocardiogramsystem can collect electrocardiogram data before and after the dosage at1030 as part of the clinical trial.

The medical monitoring device can also prepare and transmit a responseto the medication prompt at 1035. The preparation of the response can bedone automatically, i.e., without input from the individual who ismonitored. Alternatively, the preparation of the response can be basedon input from the individual who is monitored. For example, the medicalmonitoring device can present a text version of the medication prompt tothe monitored individual and then receive a confirmation that themonitored individual has medicated as instructed.

The medical monitoring device can also prepare and transmitelectrocardiogram data to the central unit at 1040. The transmitted datacan be raw or processed data. The transmitted data can correspond tospecific cardiac events of clinical significance or the transmitted datacan correspond to a representative sample of the electrocardiogram data.

The central unit can receive the electrocardiogram data and the responseto the medication prompt at 1045. The received data and response can bestored at 1050 and used to yield information about the efficacy orsafety of the medication in the context of the clinical trial.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made. Accordingly, otherimplementations are within the scope of the following claims.

What is claimed is:
 1. A method implemented by a medical monitoringsystem comprising a patient-portable electrocardiographic monitoringdevice and a central monitoring system, the method comprising: receivingat the central monitoring system electrocardiographic data from theelectrocardiographic monitoring device, storing the data at the centralmonitoring system, having the data evaluated to identify an occurrenceof a category of cardiac event, receiving from the electrocardiographicmonitoring device a request for a diagnosis, determining whether theelectrocardiographic monitoring device is authorized to receive thediagnosis, the determination being based at least in part onauthorization data received from a third-party source, obtaining adiagnosis based on the category of cardiac event, based on a result ofthe determination of authorization, transmitting an activation signal tothe electrocardiographic monitoring device, thereby enabling theelectrocardiographic monitoring device to receive the diagnosis, whereinenabling the electrocardiographic monitoring device to receive thediagnosis includes turning on at least one of a software function and ahardware function at the electrocardiographic monitoring device, andtransmitting the diagnosis to the electrocardiographic monitoringdevice, wherein obtaining a diagnosis based on the category of cardiacevent comprises distributing the electrocardiographic data to a selectedserver of two or more servers linked to the central monitoring systembased on the category of cardiac event.
 2. The method of claim 1, themethod further comprising: transmitting a signal to a medicalprofessional based on whether the diagnosis requires urgent care.
 3. Themethod of claim 2, the method further comprising: conducting a clinicaltrial, wherein conducting the clinical trial comprises: the medicalmonitoring system prompting an individual to medicate in accordance witha regimen of the clinical trial; and the monitoring service monitoringover the electrocardiographic monitoring device a cardiac function ofthe individual while the individual medicates in accordance with theregimen.
 4. The method of claim 3, wherein conducting the clinical trialfurther comprises the medical monitoring system receiving a response tothe prompt indicating that the individual has indeed medicated inaccordance with the clinical trial.
 5. The method of claim 3, whereinprompting the individual to medicate comprises the medical monitoringsystem prompting the individual to take a specific pharmaceuticalcomposition.
 6. The method of claim 3, wherein conducting the clinicaltrial further comprises determining efficacy or safety of a medicationassociated with the prompt to medicate.
 7. The method of claim 3,wherein prompting the individual comprises using theelectrocardiographic monitoring device to prompt the individual.
 8. Themethod of claim 3, wherein conducting the clinical trial furthercomprises generating, based on results of monitoring the cardiacfunction of the individual while the individual medicates, informationregarding efficacy or safety of a medication associated with the promptto medicate.
 9. The method of claim 3, wherein prompting the individualcomprises outputting a dosage of a pharmaceutical composition.
 10. Amethod implemented by a medical monitoring system comprising apatient-portable electrocardiographic monitoring device and a centralmonitoring system, the method comprising: receiving at the centralmonitoring system electrocardiogram data from the electrocardiographicmonitoring device, transmitting a first communication from the centralmonitoring system to the electrocardiographic monitoring device,receiving information at the central monitoring system indicating thatthe electrocardiographic monitoring device seeks access to one or moreservers linked to the central monitoring system, determining by thecentral monitoring system whether the electrocardiographic monitoringdevice is authorized to access the one or more servers, thedetermination being based at least in part on authorization datareceived from a third-party source, and based on a result of thedetermination, transmitting an activation signal from the centralmonitoring system to the electrocardiographic monitoring device, therebyenabling the electrocardiographic monitoring device to access the one ormore servers, wherein enabling the electrocardiographic monitoringdevice to access the one or more servers includes turning on at leastone of a software function and a hardware function at theelectrocardiographic monitoring device.
 11. The method of claim 10,wherein the at least one of the one or more servers is configured totransmit a result of evaluating electrocardiographic data to one of theelectrocardiographic monitoring device and the central monitoringsystem.
 12. The method of claim 10, further comprising: conducting aclinical trial to investigate safety or efficacy of a medication usingthe patient-portable electrocardiographic monitoring device, whereinconducting the clinical trial comprises: outputting a medication promptfrom the electrocardiographic monitoring device to prompt an individualto medicate with a medication, the electrocardiographic monitoringdevice collecting electrocardiogram data while the individual medicates,and the electrocardiographic monitoring device transmitting at leastsome of the electrocardiogram data to the central monitoring system. 13.The method of claim 12, wherein conducting the clinical trial furthercomprises receiving a confirmation that the individual has medicated asprompted.
 14. The method of claim 13, wherein conducting the clinicaltrial further comprises the electrocardiographic monitoring devicetransmitting, to the central monitoring system, information identifyingthat the individual has medicated as prompted.
 15. The method of claim12, wherein: conducting the clinical trial further comprises receiving aprompt from the central monitoring system at the patient-portableelectrocardiographic monitoring device; and outputting the medicationprompt comprises outputting the medication prompt in response to receiptof the prompt at the patient-portable electrocardiographic monitoringdevice.
 16. The method of claim 15, wherein receiving the prompt fromthe central monitoring system comprises receiving informationidentifying the medication.
 17. The method of claim 12, whereinconducting the clinical trial further comprises generating informationregarding the efficacy or safety of the medication based on at leastsome of the electrocardiogram data transmitted to the central monitoringsystem.
 18. The method of claim 12, wherein outputting the medicationprompt comprises outputting, from the electrocardiographic monitoringdevice, a dosage of a pharmaceutical composition.
 19. The method ofclaim 12, wherein conducting the clinical trial further comprisesoutputting a query related to participation of the individual in theclinical trial from the electrocardiographic monitoring device.
 20. Themethod of claim 1, wherein turning on a hardware function at theelectrocardiographic monitoring device comprises turning on acommunication link in the electrocardiographic monitoring device. 21.The method of claim 1, wherein turning on a software function at theelectrocardiographic monitoring device comprises turning on a softwarefunction enabling processing of data by a processor in theelectrocardiographic monitoring device.
 22. The method of claim 10,wherein turning on a hardware function at the electrocardiographicmonitoring device comprises turning on a communication link in theelectrocardiographic monitoring device.
 23. The method of claim 10,wherein turning on a software function at the electrocardiographicmonitoring device comprises turning on a software function enablingprocessing of data by a processor in the electrocardiographic monitoringdevice.